Diabetes Type 2, Malnutrition
Conditions
Keywords
Diabetes type 2, Malnutrition, MFG
Brief summary
Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes (MFG SNO)
Detailed description
In people with malnutrition and diabetes who require oral supplementation, there is no evidence clear when choosing a specific supplement for diabetes or a standard supplement. To date, there are no studies evaluating flash glucose monitoring in people with DM2 with supplements, nor studies comparing formulas specific for diabetes with standard formulas. Patients with type 2 diabetes, malnutrition and requiring oral nutritional supplements for 3 months will be included in the study. A standard supplement (minimum 2 per day) will be prescribed for 2 weeks, an installation of the MFG system indicating that the scans are performed at start up, at the time and two hours after taking the oral supplement at home, as it doesn't happen anymore 8 hours without scanning to avoid losing information. After 14 days participants will go to consultation to download MFG data, assess acute response after taking of the supplement in the presence of health personnel (every 15 minutes for 4 hours). Investigators will change the sensor and nutritional supplement to a specific diabetes formula, after 14 days participants will come for MFG data download and to assess acute response after taking the supplement in the presence of healthcare personnel. The results of the study will allow us to carry out a more appropriate treatment in this profile of patients, which is increasingly prevalent in our consultations.
Interventions
OTHERFortimel energy
Standard nutritional oral supplement
OTHERNutrision Advanced Diason Energy HP
Specifc nutritional oral supplement in diabetics patients
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be assigned in a 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with DM2 under follow-up by the Clinical Nutrition and Dietetics Unit (UNCYD) who present malnutrition or are at risk of malnutrition and require oral nutritional supplements, for a minimum estimated period of 3 months.
Exclusion criteria
* Patients with DM1, steroid diabetes, pancreatic diabetes, DM2 treated with rapid insulin, glomerular filtration rate less than 30 mL/min/1.73m2, intolerance to the product, gastrectomy or gastroparesis. * Patients who do not sign the consent informed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MFG discharge - mean interstitial glucose | During 14 days after taking the supplement | Interstitial glucose measured in mg/dl |
| MFG discharge - hyperglycaemia | During 14 days after taking the supplement | hyperglycaemia measured in mg/dl |
| MFG discharge - hypoglycaemia | During 14 days after taking the supplement | hypoglycaemia measured in mg/dl |
| MFG discharge - GMI | During 14 days after taking the supplement | Measured in number of scans per day |
| MFG discharge - hypoglycaemic events | During 14 days after taking the supplement | Measured in number and duration per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glucose intersticial monitoringdiabetes specific supplement | During the 4 hours after taking standard formula and the one specific for diabetes | Glucose intersticial measured in mg/dl |
Countries
Spain
Contacts
Primary ContactViyey Kishore Doulatram Gamgaram, MD, PhD.
Backup ContactGabriel Olveira Fuster, MD, PhD.
Outcome results
None listed